NCT03135106View on ClinicalTrials.gov

A Study to Evaluate the Effect of Fluconazole and Itraconazole on Erdafitinib Pharmacokinetics in Healthy Adult Participants

PHASE1CompletedINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

April 14, 2017

Primary Completion Date

September 1, 2017

Study Completion Date

September 1, 2017

Conditions
Healthy
Interventions
DRUG

Erdafitinib

A single 4-mg of erdafitinib tablet will be administered on Day 1 in Treatment A and on Day 5 in Treatment B and C.

DRUG

Fluconazole

A 400-mg fluconazole orally (4\*100 mg capsules) will be administered from Day 1 to Day 11.

DRUG

Itraconazole

A 200-mg itraconazole orally (2\*100 mg capsules) will be administered from Day 1 to Day 11.

Trial Locations (1)

2170

Clinical Pharmacology Unit, Merksem

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT03135106 - A Study to Evaluate the Effect of Fluconazole and Itraconazole on Erdafitinib Pharmacokinetics in Healthy Adult Participants | Biotech Hunter | Biotech Hunter